This invention generally relates to the field of occluding devices, delivery systems for such devices and methods of using such devices and systems in the occlusion of body passageways. The invention is particularly useful for occluding reproductive lumens such as a female patient's fallopian tubes or a male patient's vas deferens to affect contraception. Although the occlusion of a patient's reproductive lumens will be discussed herein in detail, it can be appreciated that the devices, methods and systems described herein can easily be adapted to occlude a patient's arteries or veins in a variety of situations: the nidus of an arterial-venous malformation, patent ductus arteriosis in infants, as well as feeding arteries to cancerous tumors, among other passageways. The invention also provides means for delivering vessel supporting devices such as coronary stents or venous or arterial embolic filters, to the desired location through a steerable system. Those skilled in the art will immediately recognize that various combinations, modifications, and equivalents of the inventions described herein can be used without departing from the scope of these inventions.
Conventional contraceptive strategies generally fall within three categories: physical barriers, drugs and surgery. While each have certain advantages, they also suffer from various drawbacks. Barriers such as condoms and diaphragms are subject to failure due to breakage, displacement and misplacement. Drug strategies, such as the pill and Norplant™, which rely on artificially controlling hormone levels, suffer from known and unknown side-effects from prolonged use. Surgical procedures, such as tubal ligation and vasectomy, are very effective, but involve the costs and attendant risks of surgery, and are frequently not reversible.
There exist various situations in which it is desirable to implant embolic or occlusive devices within lumens or anatomical passageways within the bodies of human or animal subjects. In a least some of those situations, it is additionally desirable to deliver a substance (e.g., a drug, a protein, cells, a biological material, a chemical substance, a gene therapy preparations, etc.) for at least an initial period of time following implantation of the embolic or occlusive device.
For example, it has been known to implant occlusive devices into the fallopian tubes of females or the vas deferens of males for contraceptive purposes. Examples of implantable occlusive devices useable for such purposes are described in U.S. Pat. No. 6,096,052 (Callister et al.) entitled Occluding Device and Method of Use and U.S. Pat. No. 6,432,166 (Callister et al.) entitled Occluding Device and Method of Use, the entireties of both such United States Patents being expressly incorporated herein by reference. Some of these devices have been constructed and/or implanted in a manner to facilitate tissue ingrowth subsequent to implantation of the device such that, after such tissue ingrowth has occurred, the ingrown tissue alone or in combination with the implanted device will provide complete occlusion of the lumen in the fallopian tube or vas deferens. Thus, during the period between implantation of the device and completion of the lumen-occluding tissue ingrowth, the lumen of the fallopian tube or vas deferens may remain at least partially open. Thus, it may be desirable to provide alternative contraceptive means to prevent unwanted pregnancy during the period between implantation of the device and completion of the lumen-occluding tissue ingrowth.
The above incorporated U.S. patent application Ser. No. 08/770,123 (Callister et al.) described various embodiments of lumen occluding devices that may be used to occlude the lumen of a fallopian tube or vas deferens, some of which may deliver a drug, such as a contraceptive agent.
The fallopian tubes tend to exude objects through peristaltic (muscular contraction) and ciliated forces, and the direction of the force varies with menstrual cycle. These forces may result in the displacement of an implant. Past implant designs have been designed to counteract these forces, examples of which are found in U.S. patent application Ser. No. 10/880,355, and Ser. No. 10/746,131, which are hereby incorporated by reference. However these designs may result in the puncture of the fallopian tube wall because they have unprotected free ends. Therefore it is desirable to incorporate a design which counteracts the forces in the fallopian tube while not completely puncturing the tube walls.